On 3 June 2026, Australia’s Therapeutic Goods Administration (TGA) provided updated information on the Database of Adverse Event Notifications (DAEN) for medical devices, an online resource that contains reports of suspected adverse events associated with medical devices supplied in Australia. The database forms part of the TGA’s post-market surveillance framework and supports ongoing monitoring of the safety and performance of medical devices throughout their lifecycle. DAEN allows healthcare professionals, manufacturers, sponsors, patients, and consumers to access information on adverse event reports that have been submitted to the TGA. These reports may involve device malfunctions, injuries, or other incidents where a medical device is suspected of contributing to an adverse outcome. The database is intended to promote transparency and assist stakeholders in identifying potential safety concerns. The TGA emphasizes that the presence of a report in DAEN does not necessarily establish that a medical device caused the reported event. Instead, the information serves as a signal for further investigation and assessment. By making adverse event data publicly available, the TGA supports informed decision-making and strengthens vigilance activities aimed at protecting public health. The database remains an important tool for detecting emerging safety issues and facilitating regulatory oversight of medical devices in Australia.
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